Axcella's NASH Candidate Shows Favorable Action In Long COVID-Related Fatigue
- Axcella Health Inc has reported topline results from the Phase 2a study to evaluate the efficacy and safety of AXA1125 in patients with fatigue related to Long COVID.
- In the study, 41 subjects were enrolled and randomized to receive either 67.8 grams per day of AXA1125 or a matched placebo.
- Subjects who received AXA1125 had improvements in mental and physical fatigue measures that were both highly statistically significant and clinically relevant compared to those who received placebo.
- Mean changes in total, physical and mental scores in the CFQ-11 versus placebo were -4.30, -2.94, and -1.32, respectively.
- Clinically meaningful shifts in physical and mental fatigue severity were also noted in subjects who received AXA1125 than the placebo.
- There was a notable trend toward significant improvement in serum lactate levels after a 6MWT in AXA1125 subjects (p=0.0730). AXA1125 was safe and well tolerated, with no significant adverse events reported by study subjects.
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